Novartis, Roche accused by Italy of eye drug 'cartel'

Competition regulators in Italy have begun a probe into whether Roche and Novartis have illegally teamed up to prevent the off-label use of Avastin for treating wet age-related macular degeneration in favour of the more expensive, but approved, drug Lucentis.

The Italian Competition Authority (ICA) has opened an investigation against Roche and Novartis with regards to "a suspected cartel in the pharmaceutical sector". The agency is acting on two complaints filed by an association of private healthcare facilities (Aiudapds) and the Italian Ophthalmological Society, which claim that the two Swiss majors "may be involved in an illicit agreement for excluding in Italy the ophthalmic use" of Avastin (bevacizumab), marketed by Roche, in order to advantage the sales of Lucentis (ranibizumab), a Roche wet AMD drug sold outside the USA by Novartis.

The ICA states that "according to several studies Avastin and Lucentis are equivalent" but notes that the latter is "far more expensive". Avastin has never been filed for wet AMD and only Lucentis is currently reimbursed by the Italian healthcare system, so as a consequence, the claimants argue that "the damages of the alleged cartel may amount to several hundreds of millions of euros per year".

The antitrust board says that it carried out inspections at the premises of some Italian branches of Roche and Novartis. The legal deadline to complete the inquiry has been set at December 20, 2013.

The Avastin/Lucentis debate has raged around the world for some time. In the USA, Roche sells both drugs but has regularly warned against off-label use of Avastin for wet AMD. However, last May, a two-year study funded by the US government revealed that the drugs are equivalent in treating the eye condition - Avastin, when used off-label for wet AMD, costs only about $50 a dose, compared with about $1,950 for Lucentis.

Last October in the UK, Novartis dropped a legal case against four primary care trusts that had been refusing to fund Lucentis and was using Avastin for wet AMD. Earlier last summer, Novartis lowered the UK price of Lucentis which in turn allowed the PCT cluster in the south of England to reverse its policy and it now recommends using only Lucentis for wet AMD.